Betamox Palatable Drops Powder for Oral Suspension 50 mg/ml

Land: Verenigd Koninkrijk

Taal: Engels

Bron: VMD (Veterinary Medicines Directorate)

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Download Productkenmerken (SPC)
14-12-2022

Werkstoffen:

Amoxicillin

Beschikbaar vanaf:

Norbrook Laboratories Limited

ATC-code:

QJ01CA04

INN (Algemene Internationale Benaming):

Amoxicillin

farmaceutische vorm:

Powder for oral suspension

Prescription-type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutische categorie:

Cats, Dogs

Therapeutisch gebied:

Antimicrobial

Autorisatie-status:

Authorized

Autorisatie datum:

1988-02-25

Productkenmerken

                                Revised: 16
th
December 2008
AN: 00097/2008
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Betamox Palatable Drops, Powder for Oral Suspension 50 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle contains:
ACTIVE SUBSTANCE:
MG
Amoxicillin…………………………………………750
(as Amoxicillin Trihydrate)
When reconstituted with 12 ml water gives a 15 ml suspension
containing amoxicillin
at a concentration of 50 mg/ml.
EXCIPIENTS:
Erythrosin E127 …………………………………..2.34
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for oral suspension
A pale red powder
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the control of infections in dogs and cats, including infections
of the alimentary
tract, respiratory tract and urogenital tract, eye and ear infections,
and skin and wound
infections. _In vitro_, amoxycillin is effective against a wide range
of Gram-positive
and Gram-negative bacteria, including:
_Bacillus cereus_
_Bordetella bronchiseptica_
_Corynebacterium _spp
_Citrobacter freundii_
_Chromobacter_ spp
_Escherichia coli_
_Flavobacter_ spp
_Pasteurella_ spp (including _P. multocida_)
_Proteus mirabilis_
_Salmonella_ spp
_Staphylococci_ (penicillin sensitive stains)
_Streptococci_
Revised: 16
th
December 2008
AN: 00097/2008
4.3
CONTRAINDICATIONS
Not to be used in animals known to be hypersensitive to penicillin.
Not to be used orally or parenterally in rabbits, guinea pigs,
hamsters or gerbils.
Caution is advised when used in any other small herbivores.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing of the
bacteria isolated
from
the
animal.
If
this
is
not
possible,
therapy
should
be
based
on
local
epidemiological information.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Penicil
                                
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